US7976501B2 - Trocar seal with reduced contact area - Google Patents

Abstract

Seal assemblies or valves, generally for use in trocar assemblies, are provided for reducing the amount of contact between an instrument being passed into and out of a trocar assembly and an inner surface of a sealing wall of such seal assemblies or valves. In one exemplary embodiment a valve includes an activation extension that is formed on the inner surface of the sealing wall of the valve and is configured such that a distal end of the sealing wall is moved to the open position by an instrument contacting the activation extension. In one embodiment the instrument does not come into contact with the inner surface of the sealing wall during the procedure. In another embodiment a distal-most end of the activation extension can be closer to a longitudinal axis extending through the flange than the inner surface of the sealing wall.

Description

FIELD OF THE INVENTION

This application relates to trocar assemblies, and more particularly to seal assemblies or valves often used in trocar assemblies.

BACKGROUND OF THE INVENTION

Surgical procedures often require a surgeon to gain access to a cavity in a patient's body. Generally, when such a procedure is required, an incision is made in an exterior wall of the cavity and an instrument is inserted into the working channel created by the incision. One common instrument used in such a procedure is a trocar assembly. Trocar assemblies include a variety of components, but generally can include a trocar cannula, a trocar obturator, and a trocar housing. In many designs, in order to access the body cavity, the trocar cannula is directed through the skin and the trocar obturator is inserted through an interior lumen defined by the cannula. The trocar obturator is then used to penetrate the skin, which has often already had an incision made in it with a scalpel or similar device, and access the body cavity. More specifically, in some designs, applying pressure against a proximal end of the trocar obturator allows a sharp point at a distal end of the trocar obturator to be forced through the skin until it enters the body cavity. Then, the trocar cannula is inserted through the perforation made by the trocar obturator and the trocar obturator is withdrawn, leaving the inner lumen of the trocar cannula as a path to access the body cavity from outside of the body.

The trocar housing can be joined to a proximal end portion of the trocar cannula, and further, the housing can define a working chamber with an open distal end portion that is in communication with the interior lumen of the cannula. Just as the interior lumen can receive the obturator, it can also receive other elongated surgical instruments such that the instruments can be axially extended into and withdrawn from the cannula through the proximal end portion of the working chamber defined by the trocar housing. For example, in order to allow a surgeon to more easily see during a procedure, an endoscope can be inserted through the cannula and proximal or into the body cavity.

It is common for a sealing assembly or sealing device to be used in the trocar assembly. Sealing assemblies and devices are often generally referred to as valves. Sealing assemblies generally help prevent fluid or gas from escaping during surgical procedures. Such prevention is needed, especially during certain minimally invasive surgical procedures, in which an insufflation gas is used to expand a body cavity. However, it can be difficult to maintain the internal gas pressure because during the course of the procedure instruments are typically passed into and out of the trocar assembly. Accordingly, a sealing assembly, and often two sealing assemblies, are generally provided in the trocar assembly. The sealing assembly can seal against an outer surface of inserted instruments and thus can prevent fluids and insufflation gas from leaving and/or entering the body cavity through the trocar cannula.

In instances where two sealing assemblies are provided, the one that is a top, or proximal, seal is usually designed to seal around a surgical instrument when it is present, and the bottom, or distal, seal is usually designed for sealing the trocar cannula when the instrument is not present. One type of distal seal is a “duckbill” seal, which is sometimes referred to as a zero-closure valve. A duckbill seal assembly generally includes a pair of opposed valve members which open and close a seal face in much the same manner a duck opens and closes its bill. The opening and closing of the duckbill seal assembly can generally result from the insertion and/or removal of an instrument from the duckbill seal assembly. More specifically, the duckbill seal assembly can generally be opened by contacting an inner surface of the seal face with the instrument. Further, the valve members can include a straight wall angle which defines a flex point for the opening and closing of the assembly, or alternatively, they can include multi-angled walls that can serve the same purpose but that can also have improved tear resistance and buckling prevention. Some examples of such valve members can be found in United States Publication No. 2005/0077688 of Voegele et al., filed on Sep. 17, 2004, and entitled “Multi-Angled Duckbill Seal Assembly,” which is hereby incorporated by reference in its entirety. An inner surface of each of the valve members and the seal face is generally in contact with an environment outside of the body cavity while an outer surface of each of the valve members and the seal face is generally in contact with an environment inside of the body cavity.

While such sealing assemblies are effective to prevent fluids and insufflation gas from leaving and/or entering the body cavity through the trocar cannula, fluid from both outside and inside the body cavity often builds up on both the inner and outer surfaces of the seal face, respectively. Thus, as instruments are passed through the sealing assemblies and come into contact with the seal face, fluid that exists on the inner and outer surfaces of the seal face is often wiped directly onto the instruments during the course of a procedure. This is especially problematic for instruments such as endoscopes and laparoscopes because fluid is often wiped directly onto the camera lens and thus obscures the surgeon's view.

Accordingly, there is a need for a seal assembly that reduces the amount of contact between instruments being passed into and out of the seal assembly and a seal face of such seal assembly.

SUMMARY OF THE INVENTION

Trocars are generally provided having one or more valves or seal assemblies provided to create a closed system between the outside environment and the environment in which the trocar is being inserted. In one embodiment a valve for use in a trocar assembly is provided and includes a valve having a flange with an aperture extending through the flange, a sealing wall extending distally from the flange and having an inner surface and a distal end that is movable between a sealed closed position and an open position, and an activation extension formed on the sealing wall and configured such that the distal end of the sealing wall is moved to the open position by an instrument contacting the activation extension. In the open position the sealing wall can be configured to receive an instrument therethrough. In an exemplary embodiment the instrument does not come into contact with the distal end of the sealing wall during the procedure. The instrument can also not contact the inner surface of the sealing wall during the procedure. The activation extensions can have a height and a width. In one embodiment a distal-most end of the activation extension can be closer to a longitudinal axis extending through the flange than the inner surface of the sealing wall. The distal-most end of the activation extension can be proximal to the distal end of the sealing wall. Further, the activation extension can come in the form of a protrusion on the inner surface and can have a substantially triangular profile. An angle formed by a contacting side of the substantially triangular profile of the activation extension and a transverse plane substantially perpendicular to a longitudinal axis extending through the flange can be more acute than an angle formed by the inner surface of the sealing wall and the same transverse plane.

In one embodiment the activation extension can be integrally formed with the sealing wall, while in another embodiment it can be made from a different material than the sealing wall. In an exemplary embodiment the material used to form the activation extension can be more rigid than the material used to form the sealing wall.

In various embodiments the sealing wall can be made of two or more seal elements, including embodiments with at least three seal elements and four seal elements. The two or more seal elements can include inner and outer surfaces and can meet at a seal face at the distal end of the sealing wall. Further, the activation extension can be a plurality of activation extensions and each activation extension can be separately disposed on the inner surface of a separate seal element of the two or more seal elements. At least one activation extension can be formed on the inner surface of each of the seal elements of the sealing wall. In one embodiment the inner surfaces of the seal elements can be configured to selectively promote movement of fluid away from a central portion of the seal elements toward a peripheral portion of the seal elements at the seal face. For instance, a central portion of each of the inner surfaces of the seal elements can be at a more proximal position than a peripheral portion of the seal elements at the seal face. In another embodiment, the inner surfaces of the seal elements can be configured to quickly evacuate fluid from a peripheral portion of the seal elements toward a central portion of the seal elements at, and subsequently beyond, the seal face. For instance, a peripheral portion of each of the inner surfaces of the seal elements can be at a more proximal position than a central portion of the seal elements at the seal face. The valve can be a duckbill seal assembly or a zero-closure valve.

In another embodiment of a valve for use in a trocar assembly, a sealing wall extends from a flange and is configured for selectively opening and closing to seal an opening of a trocar assembly when an instrument is not passed through the valve. The sealing wall can also include at least one activation extension protruding from an inner surface of the sealing wall. In an exemplary embodiment the sealing wall can be formed of a first material and an instrument contacting surface of the at least one activation extension can be formed of a second material. In a further exemplary embodiment the second material can be more rigid than the first material. The at least one activation extension can have a height and a width. When an instrument is passed through the valve, the assembly can be configured such that the instrument does not contact a distal end of the sealing wall. Alternatively, or additionally, the assembly can be configured such that when an instrument is passed through the valve, the instrument does not come into contact with the inner surface of the sealing wall. In another embodiment a distal-most end of the at least one activation extension can be closer to a longitudinal axis extending through the flange than the inner surface of the sealing wall. The distal-most end of the activation extension can be proximal to the distal end of the sealing wall.

In various embodiments the sealing wall can be made of two or more seal elements, including embodiments with at least three seal elements and four seal elements. The two or more seal elements can include inner and outer surfaces and can meet at a seal face at the distal end of the sealing wall. Further, the activation extension can be a plurality of activation extensions and each activation extension can be separately disposed on the inner surface of a separate seal element of the two or more seal elements. At least one activation extension can be formed on the inner surface of each of the seal elements of the sealing wall. In one embodiment the inner surfaces of the seal elements can be configured to selectively promote movement of fluid away from a central portion of the seal elements toward a peripheral portion of the seal elements at the seal face. For instance, a central portion of each of the inner surfaces of the seal elements can be at a more proximal position than a peripheral portion of the seal elements at the seal face. In another embodiment, the inner surfaces of the seal elements can be configured to quickly evacuate fluid from a peripheral portion of the seal elements toward a central portion of the seal elements at, and subsequently beyond, the seal face. For instance, a peripheral portion of each of the inner surfaces of the seal elements can be at a more proximal position than a central portion of the seal elements at the seal face. The valve can be a duckbill seal assembly or a zero-closure valve.

In one embodiment of a trocar assembly a housing is provided that includes two seals: a proximal instrument seal that is adapted to form a seal around an instrument inserted through the instrument seal and a distal zero-closure valve with an inner surface and a seal face. In an exemplary embodiment as least one ridge can be formed on the inner surface of the zero-closure valve. The at least one ridge can be adapted to prevent contact between an instrument inserted through the zero-closure valve and the seal face. The at least one ridge can also be adapted to prevent contact between an instrument inserted through the zero-closure valve and the inner surface. The at least one ridge can have a height and a width. The zero-closure valve can be configured to open in response to an instrument contacting the at least one ridge as the instrument is passed through the zero-closure valve. In one embodiment a distal-most end of the at least one ridge can be closer to a longitudinal axis extending through the zero-closure valve than the inner surface of the zero-closure valve. In various embodiments the zero-closure valve can include two or more seal elements, including embodiments with at least three seal elements and four seal elements. The two or more seal elements can include inner and outer surfaces and can meet at the seal face at a distal end of the zero-closure valve. Further, the at least one ridge can be a plurality of ridges and each ridge can be separately disposed on the inner surface of a separate seal element of the two or more seal elements. At least one ridge can be formed on the inner surface of each of the seal elements of the zero-closure valve. In one embodiment the inner surfaces of the seal elements can be configured to selectively promote movement of fluid away from a central portion of the seal elements toward a peripheral portion of the seal elements at the seal face. For instance, a central portion of each of the inner surfaces of the seal elements can be at a more proximal position than a peripheral portion of the seal elements at the seal face. In another embodiment, the inner surfaces of the seal elements can be configured to quickly evacuate fluid from a peripheral portion of the seal elements toward a central portion of the seal elements at, and subsequently beyond, the seal face. For instance, a peripheral portion of each of the inner surfaces of the seal elements can be at a more proximal position than a central portion of the seal elements at the seal face.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

FIG. 1 is an isometric view of one exemplary embodiment of a trocar assembly;

FIG. 2 is an isometric exploded view of the trocar assembly ofFIG. 1 with one exemplary embodiment of a seal assembly;

FIG. 3 is a side cross-sectional view of the trocar assembly ofFIG. 1 taken at line3-3;

FIG. 4 is an isometric view of the exemplary embodiment of the seal assembly ofFIG. 2;

FIG. 5 is an isometric cross-sectional view of the seal assembly ofFIG. 4 taken at line5-5;

FIG. 6 is a top view of the exemplary embodiment of the seal assembly ofFIG. 4;

FIG. 7 is a side view of the exemplary embodiment of the seal assembly ofFIG. 4;

FIG. 8 is an isometric view of another exemplary embodiment of a seal assembly;

FIG. 9 is an isometric exploded cross-sectional view of the seal assembly ofFIG. 8 taken at line9-9.

FIG. 10 is a side view of the exemplary embodiment of the seal assembly ofFIG. 8;

FIG. 11A is a top perspective view of another exemplary embodiment of a seal assembly;

FIG. 11B is a side view of the exemplary embodiment ofFIG. 11A;

FIG. 12A is a top perspective view of another exemplary embodiment of a seal assembly;

FIG. 12B is a side view of the exemplary embodiment ofFIG. 12A;

FIG. 13A is a top perspective view of another exemplary embodiment of a seal assembly;

FIG. 13B is a side perspective view of the exemplary embodiment ofFIG. 13A;

FIG. 14A is side view of the exemplary embodiment ofFIG. 4 in an initial position;

FIG. 14B is a side view of the exemplary embodiment ofFIG. 4 in a contacting position;

FIG. 14C is a side view of the exemplary embodiment ofFIG. 4 in an opening position; and

FIG. 14D is a side view of the exemplary embodiment ofFIG. 4 in a final position.

DETAILED DESCRIPTION OF THE INVENTION

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

The trocar described herein includes a seal assembly with a seal face that is configured to open without being contacted by an object, such as a surgical tool, e.g., an endoscope or laparoscope. More specifically, the seal face can be opened by a surgical tool contacting activation extensions that are associated with the seal assembly. Such contact with the activation extensions, as opposed to the seal face, can allow the object to pass through the seal face without ever contacting the seal face. This presents a number of advantages, including reducing the amount of fluid that comes into contact with the object and reducing the amount of drag on the object as it is passed in and out of the seal assembly during a surgical procedure.

Apart from the seal assembly, in accordance with the present disclosure, the general structure of the trocar assembly does not generally form part of the present invention. As such, a person skilled in the art will certainly appreciate that the present seal assembly can be adapted for use with a variety of trocar assemblies without departing from the spirit of the invention disclosed herein. Further, although the seal assembly as disclosed is generally described as being a duckbill seal assembly for a trocar assembly, a person skilled in the art will appreciate that the designs discussed herein can be equally applied to any seal assembly, not just duckbill seal assemblies, and other devices that utilize seal assemblies. A person skilled in the art will also appreciate that while the embodiments disclosed herein generally refer to the present seal assembly as a seal assembly, the seal assembly can also be described as a valve, or in some instances, a zero-closure valve.

Referring toFIGS. 1-3, atrocar assembly100 can generally include atrocar cannula102 and a trocar housing (or handle)104. Further, thetrocar cannula102 can define an interior lumen with an open proximal end portion and an open distal end portion. The proximal end portion can extend into and be mounted in adistal end portion104dof thetrocar housing104. Thetrocar housing104 can optionally include an openproximal end portion104pthat can define a workingchannel106. In one embodiment the workingchannel106 can include aproximal seal assembly108 at least partially positioned therein. In an exemplary embodiment the workingchannel106 can further include aduckbill seal assembly10 also at least partially positioned therein. As shown, for example, inFIG. 3, theduckbill seal assembly10 is positioned distal to theproximal seal assembly108 and allows for selective sealing of the workingchannel106 of thetrocar housing104. A person skilled in the art will recognize that while in an exemplary embodiment two seal assemblies are provided in the workingchannel106, in other embodiments one seal assembly, or more than two seal assemblies, can also be used in thetrocar assembly100. Further, theproximal seal assembly108 and theduckbill seal assembly10 can be secured into a desired position, at least partially within the workingchannel106 in a variety of ways. In an exemplary embodiment, acrown ring110 and agasket ring112 are snap-fit together and then thegasket ring112 is secured to thetrocar housing104. Agasket retainer ring114 can further secure the attachment between thegasket ring112 and thetrocar housing104. In one embodiment thetrocar housing104 can further include astop cock valve116 and a stopcock valve lever118, which can work together to allow and/or prevent passage of an insufflation fluid or gas, e.g. carbon dioxide, through flexible tubing into a portion of thetrocar housing104 and thetrocar cannula102.

Theproximal seal assembly108 can be adapted to cooperate with an exterior of any instrument inserted at least partially through thetrocar cannula102 such that theproximal seal assembly108 can sealingly engage the exterior of the instrument and thus can prevent the passage of fluids through thetrocar housing104 when the instrument is present within thetrocar assembly100. A variety of instruments, although primarily surgical instruments, can be inserted at least partially through thetrocar cannula102. One example of such an instrument is an endoscope or a similar device that enables visualization and/or surgical procedures during minimally invasive surgical procedures. One skilled in the art will recognize that many other instruments are known for insertion into at least a portion of thetrocar cannula102, and accordingly, that theproximal seal assembly108 can likewise sealingly engage the exterior of those instruments as well.

FIGS. 4-7 illustrate one embodiment of aduckbill seal assembly10 that can be used with a device such as a trocar assembly. As shown,duckbill seal assembly10 can generally include aseal body12 with aproximal end12pand adistal end12d, a longitudinal axis L extending through theseal body12, and a transverse plane P substantially perpendicular to the longitudinal axis L. Theseal body12 can be configured to selectively open and substantially close theseal assembly10 in response to an object, such asinstrument50, being inserted into theseal body12. In one embodiment theseal body12 can be a unitary structure, such as a sealing wall. In another embodiment theseal body12 can include a plurality of seal elements. The plurality of seal elements can also be described as two or more sealing walls. In one embodiment, the plurality of seal elements can be opposed. In the embodiment illustrated inFIGS. 4-7, twoseal elements14,16 comprise theseal body12. In other embodiments, discussed in further detail below, three or more seal elements can form theseal body12. Theseal elements14,16 can extend distally with respect to the transverse plane P from theproximal end12pof theseal body12. Theseal elements14,16 can includeinner surfaces18,20 andouter surfaces22,24, respectively, and in an exemplary embodiment theinner surfaces18,20 of theseal elements14,16 can meet at thedistal end12dof theseal body12 to form aseal face26. Further, theseal body12 and/or theseal elements14,16 can generally be configured to selectively open and substantially close theseal face26. In one embodiment theproximal end12pof theseal body12 can include aflange28 extending beyond a width of theseal body12. Theflange28 can be any shape, but in the illustrated embodiment theflange28 is circumferential. In another embodiment theseal body12 is theflange28.

The seal assembly can also include one or more activation extensions. At least one activation extension can be formed on the inner surface of at least one seal element. In the embodiment illustrated inFIGS. 4-7, oneactivation extension30 is formed on each of the twoseal elements14,16. Activation extensions can be formed on each seal element, or alternatively, activation extensions can be formed on a select number of seal elements. In one embodiment the activation extension is a ridge.

Theactivation extensions30 can be configured to open and substantially close theseal face26, either in lieu of or in conjunction with theseal body12 and/or theseal elements14,16. In an exemplary embodiment contact from an object, such as a surgical tool, with theactivation extensions30 can cause theseal face26 to open. The portion of theactivation extensions30 that an object contacts is sometimes referred to as an instrument contacting surface. Such contact by an object can result in reduced contact between the object and theseal face26. In fact, in an exemplary embodiment the object does not contact theseal face26 as it extends toward and through theseal face26.

Likewise, the contact between theactivation extensions30 and the object can also be reduced and/or minimized. Such reduced contact can be created by configuring theactivation extensions30 in a variety of ways. In an exemplary embodiment a point contact, which can be designated by an instance where the object and each of theactivation extensions30 engages only at a single point, can be created at distal-most ends30dof theactivation extensions30. In other embodiments the contact can be characterized as a line contact such that only a small portion of the activation extensions, or a limited number of single points, engages the object. In one embodiment the distal-most ends30dof theactivation extensions30 are closer to the longitudinal axis L than are theinner surfaces18,20. Further, the distal-most ends30dof theactivation extensions30 can be proximal to theseal face26. In other embodiments the distal-most ends30dare more proximal to the longitudinal axis L than they are to the respectiveinner surfaces18,20. In still other embodiments a distance between the distal-most ends30dand theinner surfaces18,20 is at least in the range of about 0.07 to 0.17 inches.

Eachactivation extension30 can come in a variety of shapes and sizes, and furthermore, can be associated with any portion of theseal body12 and/or theseal elements14,16. In an exemplary embodiment theactivation extensions30 have a substantially triangular profile. More particularly, the distal-most ends each form afirst vertex32 of the substantially triangular profile while second andthird vertices34,36 are located near the proximal anddistal ends12p,12dof theseal body12, respectively, such that a majority of a profile of theinner surfaces18,20 are covered by theactivation extensions30. In other embodiments theactivation extensions30 only cover a portion of the profile of theinner surfaces18,20, and as such, the second andthird vertices34,36 are closer together and not necessarily near either the proximal or distal ends12p,12dof theseal body12.

With specific reference toFIG. 7, an angle φ is formed betweenproximal surfaces38 of each of theactivation extensions30, which can extend from theproximal end12pof theseal body12 to thedistal-most end30dof theactivation extension30, and the transverse plane P. As illustrated, the angle φ is more acute than an angle ω formed between the each of theinner surfaces18,20 and the transverse plane P. In some embodiments the angle φ can be in the range of about ten to seventy degrees more acute than the angle ω. In one embodiment thedistal surfaces40 of each of theactivation extensions30, which can extend from thedistal-most end30dof theactivation extension30 to thedistal end12dof theseal body12, can be substantially parallel to the longitudinal axis L when theseal assembly10 is in an initial position, prior to engaging theactivation extensions30 with an object. In other embodiments thedistal surfaces40 can be undercut such that the distal most-ends30dof theactivation extensions30 are more proximal to the longitudinal axis L than thethird vertices36 of theactivation extensions30 when theseal assembly10 is in the initial position.

Although the illustrated embodiment shows the profile of theactivation extensions30 being substantially triangular, in other embodiments the profile of theactivation extensions30 can be substantially quadrilateral, substantially pentagonal, or in any other shape known to those of skill in the art. Furthermore, the sizes, distances, and other numerical values discussed herein are easily adaptable depending on the size and shape of theseal assembly10 in which theactivation extensions30 are being used. Accordingly, it is contemplated that even though a particular size and shape may not be discussed herein, it is easily ascertainable given the disclosure provided herein.

Theactivation extensions30 can be formed in a variety of ways. In one embodiment theactivation extensions30 can be integrally formed with theseal body12 and/or theseal elements14,16 from a single material. For example, theseal body12 can be made of an elastomer, such as polyisoprene, and theactivation extensions30 can likewise be formed directly from the same elastomer such that theseal body12 and theactivation extension30 form oneunitary seal assembly10. When theseal body12 also includesseal elements14,16, theseal elements14,16 can be made of an elastomer, and again theactivation extensions30 can be formed from the same elastomer such that theseal body12, theseal elements14,16, and theactivation extensions30 form oneunitary seal assembly10.

Alternatively, as illustrated inFIGS. 8-10, in otherembodiments activation extensions30′ can be a part of aseal assembly10′ by being mated to either aseal body12′ and/or sealelements14′,16′. Furthermore, in embodiments where theseal elements14′,16′ include additional components, such asribs29′ (as shown inFIG. 9), theactivation extensions30′ can be configured to be mated to the additional component(s) in lieu of, or in addition to, theseal body12′ and/or theseal elements14′,16′. A variety of mating techniques can be used to mate theactivation extensions30′ to any portion of theseal assembly10′, but in an exemplary embodiment theactivation extensions30′ are snap-fit toinner surfaces18′,20′ of theseal elements14′,16′. One benefit that a snap-fit provides is that it can allow theactivation extension30′ to be subsequently detached from theinner surfaces18′,20′. This can be beneficial when different sized objects, and thus differentsized activation extensions30′, may be desirable. In such an instance each activation extension can be specifically configured for use with a particular type and/or size object. In other embodiments theactivation extensions30′ can be mated to any portion of theseal assembly10′, not just theinner surfaces18′,20′ of theseal elements14′,16′, and it can be done using a variety of techniques, including other means of mechanical attachment and/or by the use of adhesives.

Just as theactivation extensions30,30′ can be formed in a variety of ways, they can also be formed from a variety of materials. While in one embodiment theactivation extensions30,30′ can be made from the same material as theseal body12,12′ and/or theseal elements14,14′,16,16′, in another embodiment a hybrid seal assembly can be formed. In the hybrid seal assembly at least two different materials are used to form theseal assembly10,10′. More particularly, theseal body12,12′ and/or theseal elements14,14′,16,16′ can be made of one material and theactivation extensions30,30′ can be made from a different material. In one embodiment, only the instrument contacting surfaces of theactivation extensions30,30′ are made from a different material than theseal body12,12′ and/or theseal elements14,14′,16,16′. Alternatively, three or more materials can also be used to form different components of the hybrid seal assembly. In an exemplary embodiment the material(s) used for theactivation extensions30,30′, or at least the instrument contacting surfaces, is more rigid than the material(s) used to form theseal body12,12′ and/or theseal elements14,14′,16,16′. In some embodiments theactivation extensions30,30′ are configured such that any deformation of theactivation extensions30,30′ is limited and thus can be described as being rigid or semi-rigid. In one embodiment theactivation extensions30,30′ are made of polycarbonate. Regardless of the material used to make theactivation extension30,30′, the various techniques discussed above, as well as others known to those skilled in the art, can be used to form the hybrid seal assembly.

FIGS. 11A and 11B illustrate an alternative embodiment of a seal assembly. Similar to previous embodiments,seal assembly210 can generally includeseal body212 with aproximal end212pand adistal end212d, a longitudinal axis L″ extending through theseal body212, and a transverse plane substantially perpendicular to the longitudinal axis L″.Seal assembly210 can include any and all of the same characteristics and features as discussed above with respect to sealassemblies10,10′, but while the previously illustrated embodiments included only two seal elements,seal assembly210 includes threeseal elements214,215,216. Theseal elements214,215,216 can extend distally with respect to the transverse plane from theproximal end212pof theseal body212. Theseal elements214,215,216 can includeinner surfaces218,219,220 and outer surfaces and in an exemplary embodiment theinner surfaces218,219,220 of theseal elements214,215,216 can meet at thedistal end212dof theseal body212 to form aseal face226. Further, theseal body212 and/or theseal elements214,215,216 can generally be configured to selectively open and substantially close theseal face226. In one embodiment theproximal end212pof theseal body212 can include aflange228 extending beyond a width of theseal body212.

The quick removal of fluid that can build-up in theseal assembly210 can be further achieved by configuring theinner surfaces218,219,220 of theseal elements214,215,216 such that they can quickly evacuate fluid from theperipheral portion213 of theseal body212 and toward thecentral portion213 of theseal body212. While a variety of configurations can be used to achieve this design goal, in one embodiment theperipheral portion213 can be positioned such that it is more proximal than thecentral portion211. In other words, as illustrated inFIG. 11B,peripheral portion213 is raised proximally relative to thecentral portion211.

Similar to theseal assemblies10,10′, theseal assembly210 can also include one or more activation extensions. In the embodiment illustrated inFIGS. 11A and 11B, oneactivation extension230 is formed on each of the threeseal elements214,215,216. Although it is not necessary that an activation extension be formed on each seal element, in an exemplary embodiment, theactivation extensions230 are symmetrically placed such that when an object is placed between theactivation extensions230, the object can be equally engaged around its perimeter. Further, theactivations extensions230 can include any and all of the characteristics and features discussed above with respect toactivation extensions30.

The use of threeseal elements214,215,216 as opposed to two seal elements can allow theseal face226 to open more quickly, which in turn can provide a larger and longer lasting opening for fluid caught in theseal assembly210 to exit theseal assembly210 before an object closes the opening. The removal of fluid from theseal assembly210 can be beneficial because it reduces the amount of fluid that comes into contact with an object being inserted into theseal assembly210. This is particularly important when using devices such as endoscopes and laparoscopes because the lens used by the surgeon to view the surgical site should be clear and smudge-free.

An alternative design of a seal assembly that can be effective to prevent smudging on instruments inserted into and through the seal assembly is illustrated inFIGS. 12A and 12B. Similar to theseal assembly210, theseal assembly210′ generally includesseal body212′ with aproximal end212′pand adistal end212′d, a longitudinal axis L′″ extending through theseal body212′, and a transverse plane substantially perpendicular to the longitudinal axis L′″. As illustrated, theseal body212′ also includes acentral portion211′ and aperiphery portion213′.Seal assembly210′ can include any and all of the same characteristics as discussed above with respect to sealassemblies10,10′,210, and similar to sealassembly210,seal assembly210′ includes threeseal elements214′,215′,216′. Theseal elements214′,215′,216′ can extend distally with respect to the transverse plane from theproximal end212′pof theseal body212′. Theseal elements214′,215′,216′ can includeinner surfaces218′,219′,220′ and outer surfaces, and in an exemplary embodiment theinner surfaces218′,219′,220′ of theseal elements214′,215′,216′ can meet at thedistal end212′dof theseal body212′ to form aseal face226′. Further, theseal body212′ and/or theseal elements214′,215′,216′ can generally be configured to selectively open and substantially close theseal face226′. In one embodiment theproximal end212′pof theseal body212′ can include aflange228′ extending beyond a width of theseal body212′.

Prevention of smudging by fluids on instruments inserted into and/or through theseal assembly210′ can be further achieved by configuring theinner surfaces218′,219′,220′ of theseal elements214′,215′,216′ such that they can selectively promote movement of fluid away from thecentral portion211′ of theseal body212′ and toward theperipheral portion213′ of theseal body212′. While a variety of configurations can be used to achieve this design goal, in one embodiment thecentral portion211′ can be positioned such that it is more proximal than theperipheral portion213′. In other words, as illustrated inFIG. 12B,central portion211′ is raised proximally relative to theperipheral portion213′. Other configurations that selectively promote movement of fluid away from a central portion of a seal body are discussed in U.S. patent application Ser. No. 11/771,263 of Franer et al., filed on Jun. 29, 2007, and entitled “Duckbill Seal with Fluid Drainage Feature,” which is hereby incorporated by reference in its entirety. It is understood that all of these configurations that promote movement of fluid away from a central portion of a seal body can be applied to each of the configurations discussed or referenced herein.

Similar to theseal assembly210, theseal assembly210′ can also include one or more activation extensions. In the embodiment illustrated inFIGS. 12A and 12B, oneactivation extension230′ is formed on each of the threeseal elements214′,215′,216′. Although it is not necessary that an activation extension be formed on each seal element, in an exemplary embodiment, theactivation extensions230′ are symmetrically placed such that when an object is placed between theactivation extensions230′, the object can be equally engaged around its perimeter. Further, theactivation extensions230′ can include any and all of the characteristics and features discussed above with respect toactivation extensions30,230.

Still another embodiment of a seal assembly is illustrated inFIGS. 13A and 13B. In this embodiment, four seal elements are included. Similar to previous embodiments,seal assembly310 can generally includeseal body312 with aproximal end312pand adistal end312d, a longitudinal axis L″″ extending through theseal body312, and a transverse plane substantially perpendicular to the longitudinal axis L″″. As illustrated, theseal body312 also includes acentral portion311 and aperiphery portion313.Seal assembly310 can include any and all of the same characteristics and features as discussed above with respect to sealassemblies10,10′,210,210′, but while the previously illustrated embodiments included only two or three seal elements,seal assembly310 includes fourseal elements314,315,316,317. Theseal elements314,315,316,317 can extend distally with respect to the transverse plane from theproximal end312pof theseal body312. Theseal elements314,315,316,317 can includeinner surfaces318,319,320,321 and outer surfaces, and in an exemplary embodiment theinner surfaces318,319,320,321 of theseal elements314,315,316,317 can meet at thedistal end312dof theseal body312 to form aseal face326. Further, theseal body312 and/or theseal elements314,315,316,317 can generally be configured to selectively open and substantially close theseal face326. In one embodiment theproximal end312pof theseal body312 can include aflange328 extending beyond a width of theseal body312.

Similar to theseal assembly210′, prevention of smudging by fluids on instruments inserted into and/or through theseal assembly310 can be further achieved by configuring theinner surfaces318,319,320,321 of theseal elements314,315,316,317 such that they can selectively promote movement of fluid away from thecentral portion311 of theseal body312 and toward theperipheral portion313 of theseal body312. While any of the configurations discussed or incorporated by reference with respect to sealassembly210′ can be incorporated into the design ofseal assembly310, as illustrated thecentral portion311 is raised proximally relative to theperipheral portion313.

FIGS. 14A-14D illustrate theseal assembly10 of the type shown inFIGS. 4-7 in use. In an initial position, illustrated inFIG. 14A, theseal face26 is substantially closed and an object, such asinstrument50, is not in contact with any portion of theseal assembly10. Turning toFIG. 14B, a force generally in a direction D is applied to theinstrument50, thus causing theinstrument50 to move toward theseal face26 in the general direction D until adistal end50dof theinstrument50 is in contact with at least a portion of one or more of theactivation extensions30. When theinstrument50 contacts one or more of theactivation extensions30, the duckbill seal assembly is in a contacting position. In the illustrated embodiment theinstrument50 first engages a portion of each of theproximal surfaces38 of theactivation extensions30, but in other embodiments, theinstrument50 can first engage thedistal-most end30dor thevertex32 of theactivation extensions30. As the force in the direction D continues to be applied to theinstrument50, theinstrument50 continues to move toward theseal face26, as illustrated inFIG. 14C, and can result in theseal assembly10 being in an opening position in which theseal face26 is open, theseal elements14,16 move further apart than they were in the initial position, and theinstrument50 moves distally along theactivation extensions30 toward the distal-most ends30dof theactivation extensions30. In some embodiments theinstrument50 moves distally along theactivation extensions30 and engages one or more of the distal-most ends30 of theactivation extensions30. In other embodiments theinstrument50 may not move distally along theactivation extensions30, but application of the force in the general direction D toward theseal face26 results in theseal face26 opening and theseal elements14,16 moving further apart. Once theinstrument50 is moved to its desired location beyond theseal face26, theseal assembly10 can be said to be in a final position, illustrated inFIG. 14D. In the final position theseal face26 can remain open and theseal elements14,16 can continue to be further apart than they were in the initial position. Additionally, while theseal elements14,16 can be further apart than they were in the opening position, but they do not necessarily have to be. Once theinstrument50 is done being used, it can be removed from theseal assembly10 in much the same manner as it was introduced to theseal assembly10.

Whether in the initial position, the contacting position, the opening position, or the final position, in an exemplary embodiment a system including theseal assembly10 and theinstrument50 generally creates a closed cavity between an environment below thedistal end12dof theseal body12 and an environment above theproximal end12pof theseal body12. For instance, as shown inFIGS. 14A and 14B, in both the initial and contacting positions the closed cavity is formed by theseal face26 being substantially closed. However, as seen inFIGS. 14C and 14D, in the opening and final positions the closed cavity is formed by theseal face26, theactivation extensions30, and theinstrument50. In other embodiments theinner surfaces18,20 can also help form the closed cavity. Furthermore, in instances where the cavity may not remain closed, for instance in some embodiments where two or more seal assemblies are used, the other seal assemblies can assist in creating separation between the environment below thedistal end12dof theseal body12 and the environment above theproximal end12pof theseal body12.

It is understood that even though the use of seal assemblies was only discussed with respect to sealassembly10, other embodiments of seal assemblies, for example embodiments ofseal assemblies10′,210,210′,310 can also be used in a similar manner. Likewise, even though thetrocar assembly100 was only discussed with respect to sealassembly10, other embodiments of seal assemblies, for example embodiments ofseal assemblies10′,210,210′,310 can also be used in thetrocar assembly100.

A person skilled in the art will appreciate that the seal and trocar assemblies disclosed herein have application in conventional endoscopic and open surgical instrumentation as well application in robotic-assisted surgery.

The seal and trocar assemblies disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the assemblies can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of any or all portions of the assemblies, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the assemblies can be disassembled, and any number of the particular pieces or parts of the assemblies can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the assemblies can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a seal or trocar assembly can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

Preferably, the seal and trocar assemblies described herein will be processed before surgery. First, a new or used seal or trocar assembly is obtained and if necessary cleaned. The assembly can then be sterilized. In one sterilization technique, the assembly is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the assembly and in the container. The sterilized assembly can then be stored in the sterile container. The sealed container keeps the assembly sterile until it is opened in the medical facility.

It is preferred that the assembly is sterilized. This can be done by any number of ways known to those skilled in the art including beta or gamma radiation, ethylene oxide, steam.

One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

Claims (20)

1. A valve for use in a trocar assembly, comprising:

a flange having an aperture therethrough;

a sealing wall extending distally from the flange and having an inner surface and a distal end that is movable between a sealed closed position and an open position in which it is configured to receive an instrument therethrough; and

at least two activation extensions formed on the sealing wall, spaced apart from each other when the distal end of the sealing wall is in the closed position, the activation extensions being configured such that the distal end is moved to the open position by an instrument contacting the activation extensions without the instrument contacting the distal end of the sealing wall;

wherein distal-most ends of the activation extensions are closer to a longitudinal axis extending through the flange than the inner surface of the sealing wall when the sealing wall is in the sealed closed position.

2. The valve ofclaim 1, wherein a distance between the inner surface of the sealing wall and the distal-most end of one of the activation extensions of the at least two activation extensions is in the range of about 0.07 inches to about 0.17 inches.

3. The valve ofclaim 1, wherein at least one of the activation extensions is integrally formed with the sealing wall.

4. The valve ofclaim 1, wherein at least one of the activation extensions is in the form of a protrusion on the inner surface of the sealing wall and having a substantially triangular profile.

5. The valve ofclaim 4, wherein an angle formed by a contacting side of the substantially triangular profile of the at least one activation extension and a transverse plane substantially perpendicular to a longitudinal axis extending through the flange is more acute than an angle formed by the inner surface of the sealing wall and the transverse plane.

6. The valve ofclaim 1, wherein the sealing wall is made from a first material and at least one of the activation extensions is made from a second material.

7. The valve ofclaim 1, wherein the sealing wall is two or more seal elements having inner and outer surfaces and meeting at a seal face at the distal end and each activation extension of the at least two activation extensions is separately disposed on the inner surface of a separate seal element of the two or more seal elements.

8. The valve ofclaim 7, wherein the inner surfaces of the two or more seal elements are configured to selectively promote movement of fluid away from a central portion of the seal elements toward a peripheral portion of the seal elements at the seal face.

9. The valve ofclaim 8, wherein the central portion of each of the inner surfaces of the seal elements is at a more proximal position than the peripheral portion of the seal elements at the seal face.

10. The valve ofclaim 7 wherein the inner surfaces of the two or more seal elements are configured to quickly evacuate fluid from a peripheral portion of the seal elements toward a central portion of the seal elements at, and subsequently beyond, the seal face.

11. The valve ofclaim 10, wherein the peripheral portion of the seal elements is at a more proximal position than the central portion of the seal elements at the seal face.

12. The valve ofclaim 1, wherein the at least two activation extensions are approximately symmetrically disposed around the sealing wall.

13. The trocar assembly ofclaim 1, wherein the at least two ridges are approximately symmetrically disposed around the inner surface of the seal face.

14. A trocar assembly, comprising:

a housing with a proximal instrument seal adapted to form a seal around an instrument inserted therethrough, and a distal zero-closure valve having a seal face and at least two ridges formed on an inner surface thereof, spaced apart from each other in the absence of an instrument inserted through the housing and configured to prevent contact between an instrument inserted therethrough and the seal face of the zero-closure valve;

wherein a distal-most end of the at least two ridges is closer to a longitudinal axis extending through the zero-closure valve than the inner surface of the zero-closure valve in the absence of an instrument inserted through the housing.

15. The trocar assembly ofclaim 14, wherein the zero-closure valve is configured to open in response to an instrument contacting the at least two ridges as the instrument is passed through the zero-closure valve.

16. The trocar assembly ofclaim 14, wherein a distance between the inner surface of the zero-closure valve and the distal-most end of one of the ridges of the at least two ridges is in the range of about 0.07 inches to about 0.17 inches.

17. A valve for use in a trocar assembly, comprising:

a flange having an aperture therethrough;

a plurality of seal elements extending distally from the flange, each seal element having an inner surface and a distal end that is movable between a sealed closed position and an open position in which it is configured to receive an instrument therethrough; and

at least two activation extensions, the activation extensions being formed on separate seal elements and being spaced apart from each other when the distal ends of the seal elements are in the closed position, the activation extensions being configured such that the distal ends are moved to the open position by an instrument contacting the activation extensions without the instrument contacting the distal ends of the seal elements;

wherein distal-most ends of the activation extensions are closer to a longitudinal axis extending through the flange than the inner surfaces of the seal elements when the seal elements are in the sealed closed position.

18. The valve ofclaim 17, wherein a distance between the inner surfaces of one of the sealing elements and the distal-most end of one of the activation extensions of the at least two activation extensions is in the range of about 0.07 inches to about 0.17 inches.

19. The valve ofclaim 17, wherein at least one of the activation extensions is in the form of a protrusion on the inner surface of the respective seal element and having a substantially triangular profile.

20. The valve ofclaim 19, wherein an angle formed by a contacting side of the substantially triangular profile of the at least one activation extension and a transverse plane substantially perpendicular to a longitudinal axis extending through the flange is more acute than an angle formed by the inner surface of the respective seal element and the transverse plane.

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